The Volokh Conspiracy

IRB "Ethics" Overload:

Are Institutional Review Boards (IRBs) out of control? Based on this article from the New York Times, I am inclined to say "Yes they are." (Link via Science & Law Blog.)

Alex R:
Possibly of interest:
http://institutionalreviewblog.blogspot.com/
2.28.2007 3:14pm
donaldk2 (mail):
These evident abuses should cause the law to be changed, but for sure Congress is too busy to do anything so sensible. Sociologically speaking, such boards are a haven for mischievous busybodies like this Schwetz. Another case of bureaucracy run wild.

Perhaps they can be tamed by lawsuits.
2.28.2007 3:38pm
Dennis Murashko (mail):
For those interested to learn a lot more about the various aspects of the IRBs, stay tuned for the 101:2 issue of the Northwestern University Law Review. In it, we will publish papers from the April 2006 live symposium (sponsored by the Review and Professors Jim Lindgren and Philip Hamburger) devoted entirely to the IRBs. The papers should be up on the Review's website (http://www.law.northwestern.edu/journals/lawreview/) around mid-April, with the print edition to follow around mid-May.
2.28.2007 4:46pm
Gregory Conen (mail):
I am hopeful about the lawsuits angle. After all, the way IRBs are acting now strikes me as standard risk averse bureaucracy. They have little motivation to allow research to get done (because if a professor/grad student doesn't do enough good research, it's on his/her head), but have every motivation to prevent the school from getting sued (which is on the IRB's collective head). So, they obstruct any research that has the slightest chance of a subject suing, even if the risk in minimal and the lawsuit would be baseless. The lawsuits for violations of scholarly ethics pushes them from the other direction with a stick they can understand.

But I work with plastic films. What do I know about IRBs?
2.28.2007 5:04pm
gasman (mail):
I sit on my university's IRB as a scientist member. The evidence for the mission creep hypothesis is clear here. Ten years ago it was a alms office with a few clerical workers to shuffle the paperwork and monthly meetings to aprove reviewed material. Reviewers were researchers in other areas, but shared at least the same educational background and could undestand the jargon and fundamentals of the research. We were looking for eyebrow raising practices that our colleagues, in their zeal for the science, had overlooked. We made suggestions that were often accepted without much protest and it all worked well.
Over the last decade the amount of research has increased only modestly, perhaps 20% in constant dollars, with the number of protocols reviewed being similar. The IRB office has become a bloated burocracy run by tenured professors, staffed by more than 2 dozen staff that moves mounds of paperwork. Our meetings are focused upon reams of details that would likely have no impact on any human subject, but can turn a simple questionaire study into a major hurdle. The IRB now seems proud of the fact that no researcher can conceive of a simple project in the morning, write it up in the afternoon and start collecting data within a week or two.
Once the burocracy comes alive like franensteins monster it takes on a life of its own.
2.28.2007 6:14pm
gasman (mail):
I sit on my university's IRB as a scientist member. The evidence for the mission creep hypothesis is clear here. Ten years ago it was a alms office with a few clerical workers to shuffle the paperwork and monthly meetings to aprove reviewed material. Reviewers were researchers in other areas, but shared at least the same educational background and could undestand the jargon and fundamentals of the research. We were looking for eyebrow raising practices that our colleagues, in their zeal for the science, had overlooked. We made suggestions that were often accepted without much protest and it all worked well.
Over the last decade the amount of research has increased only modestly, perhaps 20% in constant dollars, with the number of protocols reviewed being similar. The IRB office has become a bloated burocracy run by tenured professors, staffed by more than 2 dozen staff that moves mounds of paperwork. Our meetings are focused upon reams of details that would likely have no impact on any human subject, but can turn a simple questionaire study into a major hurdle. The IRB now seems proud of the fact that no researcher can conceive of a simple project in the morning, write it up in the afternoon and start collecting data within a week or two.
Once the burocracy comes alive like franensteins monster it takes on a life of its own.
2.28.2007 6:14pm
JonT:
It is interesting to me that IRB's became an issue only when they came to fields other than medicine. They are just as apt to block/delay vital research in medicine for foolish reasons. Perhaps the easiest fix would be to require that boards issue permission if any two members can be convinced the research is ethical - even if the remainder of the board has not finished deliberating.
2.28.2007 6:45pm